QLF4113 in Participants With Metastatic Prostate Cancer
ConditionProstate Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorQilu Pharmaceutical Co., Ltd.
About this trial
This is an open-label, dose-escalation and expansion Phase I clinical trial designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile, immunogenicity, and preliminary antitumor activity of QLF4113 monotherapy in participants with metastatic prostate cancer.
The Phase I trial consists of two parts: Phase Ia and Phase Ib. Phase Ia is a dose-escalation study of QLF4113 monotherapy to determine the recommended phase two dose and assess safety and PK. Then the study will proceed to Phase Ib, a dose-expansion study to further evaluate the preliminary efficacy and safety of QLF4113 monotherapy under the selected doses.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants voluntarily agree to participate and sign the informed consent form.
Male, aged ≥18 years.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
Life expectancy ≥ 3 months.
Disqualifiers
Previously treated with drugs targeting CD3 or CD2.
Significant Cardiovascular Diseases
Active, Uncontrolled Infections
Immunosuppressive Treatment before the first dose of the investigational drug
Trial design
Design model
Single group
Treatments tested in this trial
QLF4113 for injection
DrugA PSMA/CD3/CD2 antibody
Treatment groups
140 Participants
are divided into 1 treatment groupGroup A: QLF4113 dose escalation armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum tolerated dose (MTD) (Phase Ia)
Maximum tolerated dose is defined as the previous dose level at which 2 or more out of 2-6 participants experienced a dose-limited toxicity (DLT).
Time frame
From first dose of study treatment until the end of Cycle 1 (21 days)2
Maximum administered dose (MAD)(Phase Ia)
MAD is defined as follows: a) based on PK data, it is anticipated that at this dose level, the dose-exposure plateau has been reached, b) based on existing safety data, it is judged that dose escalation following this dose level will have a large safety risk or subject intolerance, or c) based on the PK-PD model, it suggested that the optimal target concentration of safety and efficacy has been explored.
Time frame
From first dose of study treatment until the end of Cycle 1 (21 days)3
recommended phase II dose (RP2D)
The RP2D will be comprehensively evaluated based on the safety, PK characteristics, and efficacy data from the Phase Ia study.
Time frame
Through phase Ia completion, approximately 1 year.4
The incidence and severity of adverse events (AE) (Phase Ib)
Incidence and severity of adverse events (AEs) evaluated according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCA) Version 6.0 (v6.0) and American Society for Transplantation and Cellular Therapy (ASTCT)
Time frame
Through phase Ia completion, approximately 1 year.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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